Quantitative MRI Evaluation of Esophageal Remodeling/Response to Treatment in Children and Adolescents With Eosinophilic Esophagitis Presenting With Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evaluation of quantitative MRI as a diagnostic option for eosinophilic esophagitis
研究概览
简要总结
To evaluate quantitative magnetic resonance imaging(MRI) as a potential non-invasive, radiation-free diagnostic tool for evaluating esophageal wall remodeling (thickness and stiffness) and response to treatment in children and adolescents with newly diagnosed eosinophilic esophagitis (EoE) presenting with dysphagia (difficulty swallowing) and food impaction.
详细描述
Eosinophilic esophagitis(EoE) is a form of chronic inflammation affecting the esophagus which often results in wall thickening and esophageal stiffening and is associated with complications, such as esophageal tears and strictures (narrowings). Chronic dysphagia and acute food impaction (swallowed food stuck in the esophagus) are common symptoms of EoE and are associated with esophageal wall thickening and stiffness.
Current diagnostic techniques such as endoscopy with biopsy give only limited information about changes in the esophageal wall in eosinophilic esophagitis(EoE). In routine clinical practice, repeat endoscopic evaluation with biopsy is commonly performed about 3-6 months after initial therapy for eosinophilic esophagitis(EoE). However, follow-up endoscopy with biopsy has drawbacks as it is invasive, costly and typically requires deep sedation or general anesthesia.
We propose to evaluate quantitative MRI as a potential non-invasive diagnostic option for evaluating esophageal wall remodeling in patients with eosinophilic esophagitis(EoE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients ages 8 to 18 years of age.
- •Pediatric patients with dysphagia(difficulty swallowing) or an episode of food impaction.
- •Pediatric patients newly diagnosed with Eosinophilic Esophagitis -
排除标准
- •Are not able to undergo an MRI without needing sedation or general anesthesia
- •Are allergic to gadolinium-based contrast material
- •Have an ongoing acute kidney injury
- •Have chronic kidney disease with an estimated glomerular filtration rate(eGFR)of <40 ml/min.
- •Have a presence of eosinophilia involving the stomach and/or esophagus.
- •Have a prior history of caustic ingestion
- •Have a prior history of esophageal surgery, including history of tracheoesophageal fistula.
- •Have known celiac disease
- •Have known Crohn's disease
- •Have known malignancy
- •Have hypereosinophilic syndrome
- •Have recent history of parasitic infection
- •Have known inflammatory bowel disease -
结局指标
主要结局
Evaluation of quantitative MRI as a diagnostic option for eosinophilic esophagitis
时间窗: 2 years
To assess noninvasive quantitative magnetic resonance imaging (MRI) based biomarkers in the evaluation of esophageal wall remodeling and response to treatment in children and adolescents with newly diagnosed eosinophilic esophagitis presenting with dysphagia. Magnetic resonance imaging (MRI)findings will be correlated with the endoscopic appearance of the esophagus, histologic findings, and clinical symptoms.
次要结局
未报告次要终点
研究者
Ethan Smith
Principal Investigator
University of Michigan